Factbox: Eisai-Biogen Alzheimer's drug success follows many failures

H Lundbeck A/S

28/09/2022 24:32

Sept 27 (Reuters) - Eisai Co Ltd  4523.T  and Biogen Inc
 BIIB.O  reported late-stage data from their Alzheimer's disease
drug lecanemab that showed it significantly slowed cognitive
decline, a big win for patients after a long string of failures
to find an effective treatment for the memory-robbing disease.
    Options are limited as Biogen's  BIIB.O  Aduhelm, the first
new Alzheimer's treatment in 20 years, has not been widely used
due to severe limits on its coverage by Medicare and insurers.
The following is a list of high profile Alzheimer's disease
trial failures: 
 Company         Drug name     Trial outcome     Mechanism of
                                                 action
 Roche  ROG.S    crenezumab    Although small    A monoclonal
                               numerical         antibody
                               differences       targeting toxic
                               favored           protein plaque
                               crenezumab, the   in the brain
                               results were not  known as beta
                               statistically     amyloid to slow
                               significant and   disease
                               potentially due   progression.
                               to chance.        
 Biogen          gosuranemab   Drug failed to    An antibody
  BIIB.O                       meet any          directed
                               efficacy goals    against "tau"
                               in trial.         proteins
                                                 believed to
                                                 play a role in
                                                 Alzheimer's.
 Roche  ROG.S    semorinemab   The drug failed   Targeted "tau"
 and AC Immune                 to slow           proteins. 
  ACIU.O                       cognitive and     
                               functional        
                               decline in        
                               trial.            
 Roche  ROG.S    gantenerumab  Combination       Designed to
 and Eli Lilly   ,             failed to arrest  neutralize
  LLY.N          solanezumab   cognitive         beta-amyloid
                               decline in those  plaques.
                                afflicted by     
                               gene mutations.   
 Neurotrope      bryostatin-1  Drug did not      Designed to
 Inc, now                      show any          induce growth
 called                        significant       of synapses in
 Synaptogenix                  difference in     the brain and
 Inc  SNPX.O                   patients after    prevent cell
                               13 weeks in a     death.
                               mid-stage trial.  
 Merck & Co      verubecestat              Did   A beta
  MRK.N                        not work in       secretase
                               late-stage        cleaving enzyme
                               trials in         (BACE)
                               patients with     inhibitor,
                               both very early   which aims to
                               Alzheimer's and   prevent amyloid
                               those with mild-  buildup. 
                               to-moderate       
                               Alzheimer's.      
 Eli Lilly and   solanezumab   In a late-stage   Targets
 Co  LLY.N                     study, patients   beta-amyloid,
                               treated with      the Alzheimer’s
                               solanezumab did   protein that
                               not experience a  forms sticky
                               significantly     plaques in the
                               greater slowing   brain.
                               in cognitive      
                               decline vs        
                               placebo.          
 AstraZeneca     lanabecestat  Companies         Beta secretase
  AZN.L , Eli                  discontinued      cleaving enzyme
 Lilly  LLY.N                  late-stage        (BACE)
                               trials of the     inhibitor,
                               drug after        which aims to
                               independent       prevent amyloid
                               committee         buildup.
                               concluded they    
                               were unlikely to  
                               succeed.          
 Johnson &       atabecestat                     BACE inhibitor 
 Johnson                       Stopped           
  JNJ.N                        development in    
                               mid-stage trials  
                               after             
                               participants      
                               showed serious    
                               elevations of     
                               liver enzymes.    
                               The company       
                               concluded the     
                               risk outweighed   
                               potential         
                               benefits.         
 Novartis        CNP520        Companies         BACE inhibitor
  NOVN.S ,                     discontinued two  
 Amgen                         mid-to-late-stag  
  AMGN.O ,                     e studies after   
 Banner                        identifying       
 Alzheimer's                   worsening of      
 Institute                     some measures of  
                               cognitive         
                               function in       
                               treatment         
                               groups.           
 Pfizer Inc      bapineuzumab  The drugmakers    Beta-amyloid
  PFE.N ,                      called off        targeting
 Johnson &                     additional work   monoclonal
 Johnson                       after the drug    antibody.
  JNJ.N                        failed to help    
                               patients with     
                               mild-to-moderate  
                               Alzheimer's in    
                               its second round  
                               of clinical       
                               trials.           
 Biogen          elenbecestat  The companies     BACE inhibitor
  BIIB.O  and                  scrapped two      
 Eisai Co                      late-stage        
  4523.T                       studies in        
                               patients with     
                               early             
                               Alzheimer’s,      
                               after             
                               independent       
                               committee         
                               recommended       
                               discontinuation   
                               due to an         
                               unfavorable       
                               risk-benefit      
                               ratio.            
 (Reporting by Bhanvi Satija, Raghav Mahobe and Manas Mishra in
Bengaluru; Editing by Bill Berkrot)
 ((Manas.Mishra@thomsonreuters.com;
www.twitter.com/Manaswrites15;))